None listed
Conditions
Interventions
Intervention1: Seriderm (TM) Non-adherent absorbent wound dressing device: Seriderm (TM) Non-adherent absorbent wound dressing device is approved in market from 2021 in India. In this study by conduct
Sponsors
Serigen Mediproducts Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, adult, human volunteer (Male and/or non-pregnant, non-lactating female) aged between 18 to 45 years. 2. Body mass index of ? 18.50 kg/m2 and ? 30.00 kg/m2 (inclusive of both) and weight ? 50 kgs for male subjects and ? 45 kgs for female subjects. 3. Subjects with no known dermatological conditions. 4. Subjects able to communicate effectively. 5. A negative urine alcohol test result. 6. A negative urine pregnancy test result for female volunteers. 7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol. 8. If study subject is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence or Is postmenopausal for at least 1 yearIs postmenopausal for at least 1 year or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
Exclusion criteria
Exclusion criteria: 1. History of contraindications or hypersensitivity to test product or any of the excipients in the formulation. 2. History of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo, or conditions known to alter skin appearance or physiologic response (e.g., diabetes or porphyria). 3. History or presence of urinary retention, gastric retention and uncontrolled narrow-angle glaucoma. 4. History or presence of any medical condition or disease according to the opinion of the investigator. 5. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 6. History of significant dermatologic cancers (e.g., melanoma or squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the topical products application sites. 7. Subjects who are on strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or inducers (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.). 8. History or presence of significant alcoholism or drug abuse in the past one year. 9. History of smoking. 10. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study enrollment. 11. An unusual or abnormal diet within 48.00 hours prior to study enrollment, for whatever reason e.g., because of fasting due to religious reasons. 12. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. 13. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 14. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 15. Respiratory rate less than 14 or more than 18 breaths per minute. 16. Major illness during 90 days before screening. 17. Consumed tobacco/tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and unwilling to follow throughout the study. 18. Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and unwilling to follow throughout the study and for 07 days following last dose of the study medication. 19. Participation in a drug research study within past 90 days prior to initiation of study. 20. Within 3 weeks of the start of study treatment, use of medications or treatments that would either: (1) significantly influence or exaggerate responses to the test product or (2) alter the inflammatory or immune response to the test product (e.g., cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin immunotherapy, monoclonal antibodies, or radiation therapy). 21. Within 72 hours of the start of study treatment, use of antihistamines or use of topical drugs at the device application site. 22. Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the irritation and contact sensitization potential of Seriderm (TM) non-adherent absorbent wound dressing device after repeated applications to the skin of healthy adult human subjects.Timepoint: Outcome will be assessed at Day 1, Day 8, Day 15, Day 22, Day 36, Day 43, Day 44, Day 45 and Day 46. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability of the test product in healthy, adult, human subjects.Timepoint: Vitals will be assessed at Day 1, Day 8, Day 15, Day 22, Day 36, Day 43, Day 44, Day 45 & Day 46. | — |
Countries
India
Contacts
Public ContactDr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
Outcome results
None listed